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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00847119
Other study ID # ML 20006. XEBERECTO/ICO/005
Secondary ID EudraCT number:2
Status Completed
Phase Phase 2
First received February 18, 2009
Last updated August 28, 2017
Start date September 2007
Est. completion date February 2015

Study information

Verified date August 2017
Source Institut Català d'Oncologia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The project objective is to evaluate the efficacy of the neoadjuvant treatment with bevacizumab, capecitabine and radiotherapy, in patients with rectal adenocarcinoma resectable locally advanced (stage T3 or T4), with or without presence of ganglionar metastases and without distant metastases.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date February 2015
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. The patient has given written informed consent prior to any study related procedure

2. Male and female aged 18 to 75 years

3. ECOG performance status 0 or 1

4. Histologically confirmed diagnostic of adenocarcinoma of the rectum < 15 cm from anal verge

5. Clinical stage of T3, T4 with/without regional lymph node metastases, without metastatic disease

6. Disease evaluable by imaging techniques

7. No tumour haemorrhage in the week prior to start of study treatment

8. External derivation in symptomatic occlusive tumours

9. Not prior cancer treatment

10. Adequate bone marrow, hepatic and renal function, defined as:

1. White blood cells = 4 x 109 /l

2. Absolute neutrophil count = 1.5 x 109 /l

3. Platelets = 100 x 109 /l

4. Haemoglobin =10 g/dl

5. Bilirubin < 1.25 x upper limit of normal

6. Aspartate transaminase and alanine transaminase < 2.5 x upper limit of normal

7. Serum creatinine = 106 µmol/l

11. Less than 10% weight loss

Exclusion Criteria:

1. Rectal cancer no amenable to resection

2. Any other malignancy which has been active or treated within the past 5 years , with the exception of in situ carcinoma of the cervix and non-melanoma skin lesions adequately treated

3. Pregnant or breast-feeding women

4. Women oh childbearing potential unless effective methods of contraception are used

5. No prior or concurrent significant medical conditions, including any of the following:

- Cerebrovascular disease (including transient ischemic attack and stroke) within the past year

- Cardiovascular disease, including the following:

- Myocardial infarction within the past year

- Uncontrolled hypertension while receiving chronic medication

- Unstable angina

- New York Heart Association class II-IV congestive heart failure

- Serious cardiac arrhythmia requiring medication

6. Major trauma within the past 28 days

7. Serious nonhealing wound, ulcer, or bone fracture

8. Evidence of bleeding diathesis or coagulopathy

9. No lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication

10. No evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug

11. No known dihydropyrimidine dehydrogenase deficiency

12. Major surgery in the 4 weeks prior to the start of study treatment

13. No concurrent chronic, daily treatment with aspirin (> 325 mg/day)

14. More than 10 days since prior use of full-dose oral or parenteral anticoagulants for therapeutic purposes

15. No participation in another clinical trial with any investigational drug within 30 days prior to randomization or during study participation

16. No other medical history or condition that, in the opinion of the investigator, would preclude study participation

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Bevacizumab
Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg.
Drug:
capecitabine (Xeloda)
Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period
Radiation:
Rectal Radiotherapy
Radiotherapy in rectum 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week.

Locations

Country Name City State
Spain Institut Català d'Oncologia-L'Hospitalet L'Hospitalet del Llobregat Barcelona

Sponsors (2)

Lead Sponsor Collaborator
Institut Català d'Oncologia Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

References & Publications (1)

PHASE II STUDY OF PREOPERATIVE BEVACIZUMAB, CAPECITABINE, AND RADIOTHERAPY FOR RESECTABLE LOCALLY ADVANCED RECTAL CANCER. M. Martinez Villacampa, C. Santos, M. García, V. Navarro, A. Teule, F. Losa, A. Pisa, L. Lema, S. Biondo, R. Salazar. J Clin Oncol 29

Outcome

Type Measure Description Time frame Safety issue
Primary Pathologic complete response rate. % patients with pathologic complete response (absence of tumoral cells in the resected piece) Surgery date
Secondary Overall clinical response Surgery date
Secondary To determine the downstaging caused by treatment Surgery date
Secondary relapse free survival Time of radiological evidence of relapse.
Secondary Quantify the local control grade: R0 resections in surgery Surgery date
Secondary Local relapse and distant relapse rates Relapse date
Secondary To determine the security profile of this neoadjuvant treatment (radio- chemotherapy) From date of register to surgery date
Secondary Surgery complication rate During surgery admission.
Secondary To determine the angiogenic profile changes in tumour. 15 days, 6 weeks and 4 months
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